Toric Performance And Constant Evaluation (PACE)

Prospective Assessment of Constant Optimization and Visual Outcomes Following Monofocal Toric IOL Implantation

The main purpose of this investigation is to support safety and performance assessment of the investigational device with a focus on optimizing the IOL constants based on refractive outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Device: Monofocal toric IOL

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Grant Sharpe; Phone Number: +447918937014; Email: grant.sharpe@zeiss.com
• Study Contact Backup: Name: Linda Villanueva; Phone Number: 7143226506; Email: linda.villanueva@zeiss.com

Study Locations

• Czechia
  • Prague, Czechia
    • Oční Centrum Praha
    • Contact: Study Coordinator
    • Principal Investigator: Andrea Janeková
  • Prague, Czechia
    • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha
    • Contact: Study Coordinator
    • Principal Investigator: Iveta Němcová
  • Prague
    • Prague, Prague, Czechia, 18100
      • Oční klinikaO
      • Contact: Petra Kasakova; Phone Number: +420734579078; Email: kasakova@premiumclinic.cz
      • Principal Investigator: Jiří Pašta
• Germany
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
    • Contact: Raquel Amroussi; Phone Number: +4966215636849; Email: raquel.willrichamroussi@med.uni-heidelberg.de
    • Principal Investigator: Gerd Auffarth
• Spain
  • Alicante, Spain, 03001
    • Ofatlivist Alicante
    • Contact: José Rubio; Email: jmrubio@oftalvist.es
    • Principal Investigator: Pedro Tañá
• United Kingdom
  • Ayrshire
    • Ayr, Ayrshire, United Kingdom, KA7 2SP
      • Ayrshire Eye Clinic
      • Contact: Study Coordinator; Phone Number: +44 1292 282100; Email: info@ayrshireeyeclinic.com
      • Principal Investigator: Satish Srinivasan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older;
• Patients willing, able, and with sufficient cognitive awareness to comply with examination procedures and schedule for follow-up visits;
• Patients with clinically significant age-related cataract (cataract grades of 1, 2, 3 on the LOCSIII scale, but otherwise healthy, requiring surgical treatment, and scheduled for unilateral or bilateral phacoemulsification or Femtosecond-Laser-Assisted cataract surgery;
• Patients with existing regular corneal astigmatism of minimum 0.75 D in at least the first eye to be operated.
• Signed informed consent form;
• Corrected distance visual acuity projected to be better than 0.2 logMAR after the cataract surgery, as determined by Investigator's medical judgment;
• Calculated IOL power within the range of the investigational IOL; SE +18.0 D to +28.0 D (0.5 D Steps), and between a Cylinder range of +1.0 D to +2.5 D (0.5 D Steps);
• Dilated pupil size large enough to visualize TIOL axis markings postoperatively; at least 5.5mm;
• Clear intraocular media other than cataract.

Exclusion Criteria:

• Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject;
• Keratometric astigmatism (assessed by IOL Master) of minimum 0.75 D in the first eye
• Traumatic cataract;
• Pregnancy or lactation;
• Concurrent participation in another drug or device investigation within the last 30 days;
• Irregular astigmatism;
• Instability of keratometry or biometry measurements;
• Subjects wearing contact lenses as standard vision aid;
• Abnormal pupil;
• Any anterior segment pathology that could significantly affect outcomes (e.g. chronic or recurrent uveitis, iritis, aniridia, rubeosis iridis, etc.);
• History of concurrent intraocular inflammation;
• Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or clinically significant corneal membrane dystrophies);
• History of any clinically significant retinal or ocular pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmus, epiretinal membrane, Choroidal hemorrhage etc.) in the study eyes that could alter or limit final postoperative visual prognosis;
• Pseudoexfoliation syndrome (according to investigator judgement);
• Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment;
• All kind of infections (acute ocular disease, external / internal infection, systemic infection);
• Monophthalmic patient;
• Patients, who are unable to fixate for a longer time, e.g. strabismus, nystagmus, Parkinson disease
• Patient expected to require retinal laser treatment before the end of the last follow-up examination;
• Patient expected to require refractive laser treatment / refractive laser touch-up before the end of the last follow-up examination;
• Patients who may be reasonably expected to require a secondary surgical intervention at any time during the investigation (other than Nd:YAG capsulotomy)
• In case of both eyes included in this trial: Patients who need to undergo surgery on both eyes on the same day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral or bilateral implantation of investigational device	Device: Monofocal toric IOL; The device under investigation is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens indicated for aphakia after surgical extraction of the cataractous natural lens and is also indicated for the correction of regular corneal astigmatism.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive predictability	Difference between predicted Manifest Refraction Spherical Equivalent and achieved Manifest Refraction Spherical Equivalent at the final postoperative visit: Percentage of first implanted eyes within ± 1.0 D	From preoperative visit to the final postoperative visit at twelve months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refractive outcomes	Manifest Refraction: Sphere, Cylinder, Manifest Refraction Spherical Equivalent	From preoperative visit to the final postoperative visit at twelve months
Refractive predictability	Percentage of eyes within ± 0.25 D, ± 0.5 D, & ± 1.0 D	From preoperative visit to the final postoperative visit at twelve months
Reduction in cylindrical power	The change in manifest refractive cylinder from baseline to the final postoperative visit.	From preoperative visit to the final postoperative visit at twelve months
IOL Rotation	Percentage of IOLs with IOL rotation with less than 10 and 20 degrees.	From preoperative visit to the final postoperative visit at twelve months
Stability of IOL axis orientation	Expressed as percentage of IOLs that rotate ≤ +/- 5 degrees postoperatively	Between 30 to 60 days and 120 to 180 days
Axis Misalignment	The absolute difference between intended IOL axis orientation and measured IOL axis orientation with less than 10 and 20 degrees.	From baseline to postoperative visit 120-180 days
Monocular Uncorrected Distance Visual Acuity (UDVA)		12-Month Postoperative
Percentage of eyes that achieve UDVA within 0.0 and 0.30 logMAR or better		12-Months Postoperatively
Monocular Best-Corrected Distance Visual Acuity (CDVA)		12-Months Postoperatively
Monocular Uncorrected Intermediate Visual Acuity (UIVA)		12-Months Postoperatively
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)		12-Months Postoperatively
Monocular (1st eye implantations) defocus curve		12-Months Postoperatively
Binocular defocus curve on subjects implanted binocularly		12-Months Postoperatively
Intraocular Pressure		12-Months Postoperatively
Assessment of subject satisfaction, patient reported outcomes, and spectacle independence		12-Months Postoperatively
IOL observations	IOL Decentration, Tilt, Discoloration, Opacity, Glistenings	12-Months Postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preservation of Corrected Distance Visual Acuity	Rate of eyes with postoperative CDVA 0.3 logMAR or better	12-Months Postoperatively
Contrast Sensitivity		Six-Months Postoperatively
Posterior Capsule Opacification	Rate of occurrence and grading	12-Months Postoperatively
Rate of performed and planned Nd:YAG laser capsulotomies		12-Months Postoperatively
Signs of intraocular inflammation	Anterior chamber cells following Standardization of Uveitis Nomenclature (SUN) grading scheme; Anterior chamber flare following SUN grading scheme; Vitreous cells, following National Institutes of Health (NIH) grading scheme; Cystoid macular oedema; Hypopyon; Endophthalmitis	12-Months Postoperatively
Slit lamp biomicoscopy	Eyelid; Conjunctiva; Corneal Edema; Other corneal abnormalities	12-Months Postoperatively
Fundus examination	Retina; Macula; Optic Nerve	12-Months Postoperatively
Adverse event rate of Posterior Chamber IOL	As per ISO 11979:2024	12-Months Postoperatively

Collaborators and Investigators

• Sponsor: Carl Zeiss Meditec AG
• Collaborators: targomedGmbH
• Investigators: Principal Investigator: Gerd Auffarth, Dr. Med, University Hospital Heidelberg; Principal Investigator: Andrea Janeková, MD, Ph.D, Eye Centre Prague; Principal Investigator: Iveta Němcová, MD, Ph.D, Military University Hospital, Prague; Principal Investigator: Jiří Pašta, Doc.MUDr, Premium Clinic; Principal Investigator: Satish Srinivasan, M.D, Ayrshire Eye Clinic; Principal Investigator: Pedro Tañá, M.D, Oftalmología Vistahermosa S.L

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: GPAS-SAS-026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No